research
Clarissa de Assumpção1, Nínive da Silva Pinto2, Luis Guillermo Coca Velarde3, Osvaldo José Moreira do Nascimento4, Beni Olej5
Abstract
The informed consent form (ICF) is a document which explicitly conirms the consent of a paricipant in a re -search project, and should contain all necessary informaion clarifying the study in which the subject intends to paricipate. This study evaluates the level of comprehension of an ICF signed by 146 volunteers using a self-administered instrument. The average age of the sample was 47.29 years, and there was a prevalence of women (67.2%), incomplete primary educaion (53.4%) and no private health care (93.2%). The mean score of correct answers of 146 respondents was 53.1%. There was no associaion between the percentage of correct answers and the variables of gender, age, educaion and ime of response. There was a signiicant associaion between taking the ICF home and the percentage of correct answers. The average value of correct answers found was not acceptable and educaional measures must be implemented, seeking an increase in compre -hension and the safety of paricipants.
Keywords: Informed consent. Comprehension. Human experimentaion.
Resumo
Compreensão do termo de consenimento em pesquisa clínica
O termo de consenimento livre e esclarecido (TCLE) é documento onde se explicita o consenimento do par -icipante, contendo todas as informações necessárias para que seja elucidada a pesquisa da qual se propõe paricipar. O objeivo deste trabalho foi avaliar o nível de compreensão do TCLE assinado por 146 voluntários, uilizando instrumento de coleta de dados autoaplicável. A média de idade foi 47,3 anos, com prevalência de paricipantes do gênero feminino (67,2%), ensino fundamental incompleto (53,4%) e sem assistência privada de saúde (93,2%). A média de acertos foi 53,1%. Não houve associação entre o percentual de acerto e as variáveis gênero, idade, escolaridade e tempo de resposta. Houve associação signiicaiva entre levar a via do TCLE para casa e o percentual de acerto. O valor médio de acertos evidenciou a necessidade de novas medi -das educaivas, buscando aumentar a compreensão e a segurança dos paricipantes.
Palavras-chave: Consenimento livre e esclarecido. Compreensão. Experimentação humana.
Resumen
Comprensión del consenimiento informado en la invesigación clínica
El consenimiento libre, previo e informado (CLPI) es un documento en el cual se explicita el consenimiento del paricipante, conteniendo toda la información necesaria para la elucidación sobre la invesigación en la cual se propone paricipar. El objeivo de esta invesigación fue evaluar el nivel de comprensión del consen -imiento informado irmado por 146 voluntarios uilizando un instrumento auto-aplicable para la recolección de datos. La edad promedio fue de 47,3 años, con prevalencia de paricipantes de género femenino (67,2%); educación primaria incompleta (53,4%) y sin cobertura privada de salud (93,2%). El promedio de aciertos de los 146 entrevistados fue de 53,1%. No hubo asociación entre el porcentaje de respuestas correctas y las variables de género, edad, educación y iempo de respuesta. Hubo una asociación signiicaiva entre la posibilidad de llevarse el consenimiento informado a la casa y el porcentaje de respuestas correctas. El valor promedio de aciertos encontrado destacó la necesidad de nuevas medidas educaivas, buscando aumentar la comprensión y la seguridad de los paricipantes.
Palabras-clave: Consenimiento Informado. Comprensión. Experimentación humana.
Aprovação CEP Hospital Universitário Antônio Pedro/UFF 251/11
1. Mestre clarissa@upc.uf.br 2. Mestranda ninive.upc.uf@gmail.com 3. Doutor guilleco@terra.com.br 4. Doutor osvaldo_nascimento@ hotmail.com 5. Doutor beni@upc.uf.br – Universidade Federal Fluminense (UFF), Niterói/RJ, Brasil.
Correspondência
Clarissa de Assumpção – Rua Marquês de Paraná, 303, 4º andar da Emergência – Centro CEP 24033-900. Niterói/RJ, Brasil.
Declaram não haver conlitos de interesse.
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The history of research involving human beings has taken perverse and doubful paths, involving ep -isodes of mysicism and cruelty: mass sterilizaion processes 1, medical experiences with prisoners of war 2, monitoring of untreated syphiliic men 3, etc. Nevertheless, in some moments, suitable standards were established for studies with humans, such as the Nüremberg Code 4 and the Helsinki Declaraion 5. The need to establish ethical and regulatory princi -ples became gradually clear, so that they could guide research with human beings and minimize industrial and inancial interests, or totalitarian ideologies and systems.
In this context, the concept of autonomy emerges worldwide, which determines the free -dom of the individual to freely manage their life, raionally making their choices. For an individual to paricipate in a clinical trial, they should be in -formed, enlightened and assured of their rights and duies, in order to formalize their free decision. The free and informed consent (IC) is an instrument used in health services to record the agreement of a subject to perform a certain procedure. The IC ap -plicaion process and the free understanding of the subjects are essenial to ensure the autonomy of the individual and respect for their choices, their life, their body and their social relaionships.
In the year 1901, in Prussia, the government approved an instrucion on medical intervenions with non-diagnosic, therapeuic or immunizaion purposes, including criteria such as the paricipa -ion of minors, consent and clariica-ion 6. According
to Melo and Lima, in the year 1931 the Ministry of the Interior of Germany established detailed
regula-ions on diferent therapeuic procedures of human experimentaion 7, which aimed to curb abuse and
disrespect for human dignity in research, because the paricipant needed to authorize the procedures that would be carried out. With the rise of Nazism, the concept of human being was redeined and, consequently, those who could enjoy such protec -ion, resuling in research pracices that shocked humanity.
Ater the world discovered the atrociies com -mited in World War II, several segments mobilized themselves and developed guidelines and standards aimed to ensure the autonomy of the individual, who were used unil then as guinea pigs in scieniic experiments. The creaion of the Nuremberg Code 4 (1947), ater the trial of war crimes in Nazi camps, and the Declaraion of Helsinki 5 (1964), drated by the World Medical Associaion, led the scieniic community to a more respecful research conduct
and directed toward the paricipant’s autonomy, with their consent as the autonomy foundaion.
However, obtaining the signed document – In -formed Consent (IC) – does not mean that there was free, independent, voluntary, open consent and that the paricipant has really understood all the risks and beneits of the acion. Several factors (paient’s stress, educaional level, economic vulnerability, access to health services) can be limitaions to the perfect exercise of free and informed consent. In the research ield, the relaionship with the physician or health professional also inluences the volunteer’s decision-making process.
For Bento, Hardy and Osis 8, members of the working classes without a higher educaion degree are unable to evaluate the technical competence of a physician and therefore they focus their evaluaion in aitudes – for example, if the physician is kind, dedicated and calm. The physician-paient relaion -ship is an addiional item to this factor and it creates one more step in obtaining consent. Some authors ideniied signatures under coercion, caused by the provision of treatment, by social asymmetries be -tween researcher and paricipant 9-10, by secondary
inducion to the remuneraion of paricipants under economic hardship 11 or even by ofering access to health care services 12.
Gradually, an increasing number of aricles were published that demonstrate that signing the IC form does not represent any guarantee that the process to obtain it had respected the paricipants’ freedom of choice. Many studies show 13-18 misap-prehension by volunteers on the experimental and therapeuic aspects of clinical trials; in fact, some may not be even aware that they are paricipaing in the research 19. Others may believe that the research is conducted primarily for their own beneit, and not for general knowledge or for the beneit of future paients 20, a belief that has been called therapeuic
misconcepion 21.
The quality of informed consents is, according to Paris et al. 22 obviously insuicient, and meth -ods require improvement so that the volunteers’ understanding is also improved. Some studies difer -eniate subjecive understanding (that which shows what the volunteer thinks they understood) from objecive understanding (what the volunteer really understood). In this study 22, only objecive under -standing was taken into consideraion because, for them, the important thing was that volunteers had a genuine understanding without considering the noion of having understood.
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Discussions on these issues contributed to the emergence of greater interest in evaluaing the consent process. Greater atenion was given to the strategies of research groups to invite paricipants and inform them of the research aciviies and pur -poses, indicaing the use of group dynamics, printed materials and videos to obtain their signatures on the informed consent form. Especially in contexts where the educaional level among the populaion is low, these strategies, when well implemented, have a far greater protecion efeciveness than a simple check of language adequacy on the informed consent form and their check list, a mandatory part of the IC 23.
This study was conducted in order to assess the level of understanding of the IC based on the re -sponses to the survey developed in accordance with the score percentage, relaing it to some variables obtained in speciic survey.
Method
This is a descripive survey with quanitaive and qualitaive approach. The volunteers were selected due to their contact with researchers of Antônio Pedro University Hospital, at the Federal Fluminense University (UFF), from six diferent stud -ies performed at the clinical research unit of UFF, each study having their research team. The surveys were applied by two nurses in private rooms with -out interference of the researchers from each team. Men and women were included in the re -search, who signed a research IC form in the last thirty days. Paricipants were submited to a closed survey, validated by two professionals working in the ethics ield. A test of the instrument was con -ducted with ive people, of both sexes, who had diferent educaional levels: one with incomplete primary educaion, two with incomplete secondary educaion and a high school graduate.
Ater signing the IC, each volunteer received a copy of the understanding assessment survey and were instructed on how to ill it out. When the whole process was understood, the staring ime of the survey was recorded; when they inished answer -ing it, the end-ing ime was informed. The second survey, whose response ime was not recorded, evaluates the way of obtaining the IC and consists of ive statements. The volunteer must choose one of three responses: “yes”, “no” or “Ido not know”.
Tables containing absolute frequencies (n) and relaive frequencies (%) were presented to conduct
the staisical analysis of categorical variables such as gender, age, educaion and healthcare insurance. The remaining responses were analyzed by associa -ion tests of categorical variables, such as Chi-square and Fisher exact tests. In the case of igures, mean comparison and associaion tests were used accord -ing to the data characterisics. They were considered staisically signiicant for analysis of p values < 0.05.
Data were analyzed by categorizaion, accord -ing to the created themes based on the type of statement answered in the survey. Those statements that solely relied on the provision of informaion by the professional responsible for the informed con -sent process were classiied as objecive. The others were classiied as subjecive statements, in which informaion relied on the volunteer’s interpretaion and understanding.
The staisical program used for data analysis was Sigmastat 3.1. The study was conducted in ac -cordance with the current legislaion.
Results
The sample consisted of 146 subjects random -ly selected from six diferent studies at the clinical research unit of UFF. The addressed topics were neu -rology, cardiology, dermatology and pulmonology. Each paricipant belonged to only one study. Since the surveys were ideniied by sequenial numbers, it was not possible to determine how many parici -pants belonged to each area. Data collecion began in December 2012 and ended in January 2014.
Table 1. Sample distribuion according to socio-economic and response ime variables (n=146)
Gender no. (%)
Male 45 (30.8)
Female 101 (69.2)
Educaional Level
Elementary school dropouts 78 (53.4) Elementary school graduates 5 (3.4) High school dropouts 31 (21.2) High school graduates 24 (16.4)
College dropouts 6 (4.1)
College graduates 2 (1.5)
Health care insurance
Yes 10 (6.8)
No 136 (93.2)
The mean age was 47.29 years, with a min -imum of 20 years, a max-imum of 73 years and
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a standard deviaion of 12.21. There was a pre -dominant number of female paricipants (69.2%), incomplete primary educaion (53.4%) and absence of private health care (93.2%). The average re -sponse ime to the surveys was 6.91 minutes, with a minimum of 3 minutes and maximum of 17 min -utes (Table 1). There was no staisically signiicant correlaion between educaional level and survey compleion ime (p = 0.36).
Overall assessment of the IC knowledge per statement
The volunteers’ responses were analyzed for accuracy and error, based on the iniial evaluaion of two bioethics scholars of Antônio Pedro Univer -sity Hospital, who validated the survey. The overall assessment of knowledge was calculated and cate -gorized in knowledge levels: low (> 25% of expected responses), moderately lower (25% to 50%), mod -erately higher (50% to 75%) and high (<75% of expected responses). This classiicaion used inter -quarile ranges (P25, P50, P75) in a similar manner to that described in the literature 24.
According to assessment of 15 statements, it was observed that the error or accuracy score is not homogeneous to individual quesions. Four state -ments (1, 3, 4 and 9) – 26.6% of the total – had a high percentage of knowledge, and the same per -centage (26.6%) was obtained in quesions rated as low level (7, 12, 15 and 16). The responses to other quesions were categorized as moderately higher (2, 5, 13 and 14) and moderately lower knowledge (10, 11 and 17), respecively 26.6% and 20% of the set. Statements 6 and 8 were not evaluated because there are several types of studies with diferent de -signs, therefore, there is not a single correct answer.
Overall assessment of knowledge per paricipant Ninety paricipants (61.6%) had a moderate -ly higher knowledge of the IC informaion, with accuracy score between 52.9% and 72.2%. Only one respondent (0.7%) scored higher than 75%. A respondent scored below 25% (0.7%), and 54 par -icipants (37%) had a score between 25% and 50%. There was no staisically signiicant correlaion between accuracy score and educaional level (p = 0.82), gender (p = 0.7), age (p = 0.2) and response
ime (p = 0.87).
Data categorizaion
The statements submited to the survey par -icipants were categorized into two groups: one
with objecive informaion about the study, and the other with subjecive informaion.
Objecive informaion
Most paricipants believed that the IC had been evaluated by an ethics group (statement 2 – 70.5%). When the paricipants were asked about the length of the study (statement 5), 69.2% of them conirmed the informaion given by the phy -sician during the informed consent process, 28.8% said they were not informed, and 1.3% did not know how to answer it. On the research originality and its procedures and treatment (statement 6), 41.8% believed that they were all new. In relaion to third party access to collected data (statement 9), 79.5% thought that others could have access to them, 17.8% did not think so, and 2.7% did not know how to answer it.
Regarding the liability for injuries and/or dis -eases resuling from research (statement 12), 59.6% of the paricipants said they did not know who would be the party responsible in case of indemnity, 33.6% did not know how to answer it and only 6.8% said they had been properly informed. For the report -ing of adverse events or just to have their doubts cleared about the research, most respondents had the phone number of the physician responsible for the study (statement 13 – 69.9%). Most paricipants did not know how many volunteers were part of the research (statement 15 – 87.7%). Concerning the informaion that research could be interrupted at any ime (statement 16), most volunteers were not aware of that (82.9%), and only 11.6% knew that this could occur.
Subjecive informaion
In relaion to the respondents’ understanding regarding their paricipaion in a study when they signed the IC (statement 1), 89.7% said they were aware of it, and 10.3% claimed they did not to know about it. When faced with the informaion that the main reason of the research is to improve the future treatment compared to the current therapy (state-ment 3), most paricipants agreed (84.2%), and some paricipants found that the main objecive is to improve the treatment that is being performed at the moment (15.8%). The percepion that they are helping future paients (statement 8) appears in the answers of 95.9% of respondents. Regarding the volunteers’ responsibility in the study (statement 4), 77.4% said they had duies and responsibiliies, and 20.5% denied this fact. As for direct research
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beneits (statement 7), the majority (82.9%) thinks there is some beneit, and only 15% acknowledge that it is likely that the research does not bring any beneits.
The idea of research conideniality (statement 10) was unknown by the majority of respondents (67.1%). Moreover, there was a high percentage of paricipants who reported the research as the only alternaive ofered by the physician who monitored them (statement 11 – 62.3%). The permanence in the research as a paricipant’s choice was conirmed by 73.3% of respondents (statement 14), and the knowledge of changes during the treatment (state -ment 17) was airmed by 47.3% of them.
Procedures for obtaining the IC form
In relaion to the 146 respondents, 32.2% of them said they had not taken their IC copy home. Most respondents reported having read the IC alone (78.1%), without the help of a friend or rel -aive to understand the content (84.2%), but with physician’s explanaion before signing it (76.7%). In regard to the formaion of groups for a brief expla -naion of the study, 97.9% of respondents conirmed that they had not paricipated in this type of event. There was a signiicant associaion between taking their IC copy home and the accuracy score per re-spondent (p < 0.05) (Table 2).
Table 2. Associaion between the IC process and accuracy score (n = 146)
Airmações no. % P
I took the IC form home Yes
No
I don’t know
99 47 0 67.8 32.2 0 0.0027 I read the IC form alone
Yes No
I don’t know
114 28 4 78.1 19.2 2.7 0.82 A relaive or friend helped me understand the IC form Yes
No
I don’t know
23 123 0 15.8 84.2 0 0.93
The physician (or other professional) explained the IC form to me
Yes No
I don’t know
112 34 0 76.7 23.3 0 0.74
The physician (or professional) discussed the IC form with me and other group paients
Yes No
I don’t know
3 143 0 2.1 97.9 0 0.2 Discussion
The mean accuracy score of the 146 respon -dents was 53.14%, which is close to the score found by Araújo 24 in Minas Gerais – despite using diferent collecion instruments and approaches - but lower than the scores found by other researchers in devel -oping and developed countries 25-29. However, more
research is required for precisely staing the level of understanding among research paricipants in sev -eral regions of Brazil.
Christopher et al. 30, in a study on the readabil -ity of informed consent forms with 154 paricipants in biomedical research on mental illness, found that 35% of the populaion did not have the minimum educaional level required to understand the docu -ment. In another study, Riecken and Ravich 31, 28% of 156 war veterans, interviewed ten weeks ater signing the IC, did not know they had been includ -ed in a study, and only 10% of them were able to correctly explain the research objecives. According to the same line of study, in an oncologic study in the United States 32, 74% of paricipants did not un -derstand that the proposed treatment was not the standard treatment, when they were included in the study.
In our study, there was no associaion be -tween accuracy score and gender, age, response ime and educaional level variables. This difers from the studies of Araújo 24, Rajaraman et al. 33 and Jofe 29. The study developed by Fitzgerald et al. 34 in Haii, with poorly educated volunteers, found that research paricipants from developing countries are able understand more than 80% of a complex IC if iniiaives are taken to secure this knowledge, in -stead of a simple meeing with the researcher.
A study developed in 2007 35 demonstrated a mulivariate analysis of factors that hinder the un -derstanding of the IC and found that paricipants who best understand the texts are those with high -er educaional levels, with reading habits, Int-ernet access facility and with a higher income. Contrary to our expectaions and what is evidenced in the liter -ature, the respondent with the highest percentage of correct answers (82.9%) did not have the highest educaional level. This can be explained by the en -gagement and commitment of some subjects with their treatment, which is independent of their so-cial and educaional levels. Private medical paients, with good social and educaional level, oten fail to understand certain prescripions, requiring assis -tance to organize their drug intake schedules.
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Cohn et al. 36 demonstrated that the most ef-icient method to improve understanding of the volunteer is the inclusion of a third person – although this is not always suicient – the research team or an individual unrelated to the research, who could spend more ime discussing informaion with the vol -unteer. For Bento et al. 8, the consent approach in two stages (individual and group) provides an expectaion of expanded understanding, because in a group the answers to quesions of a paricipant can clarify oth -ers or raise new quesions. In paricular, paricipants may feel more at ease to formulate inimate ques -ions, dispelling doubts on aspects of the research that seemed inimidaing to expose to the group.
The Census of Insituto Brasileiro de Geogra -ia e Estaísica (Brazil-ian Insitute of Geography and Staisics – IBGE) 39 in the municipality of Niterói
showed that 24% of the populaion have not com -pleted elementary educaion, 12.7% of them have completed elementary educaion, 28.8% are high school graduates and 23.9% have a college degree. The populaion distribuion is not the same found in this study, which reinforces the idea that the scenar-io under study does not relect society as a whole, only the porion that seeks public health care.
Social vulnerability permeates many issues addressed in this study. Although there was no signiicant associaion and due to not being an un -expected fact, 93.2% of respondents do not have private health insurance, and public health services are the only resource available for treatment and follow-up – a higher percentage than the one pre -sented by Silva et al. 38: in the year 2003, 82.8% of subjects, and in 2008 it was reduced to 79.9%. A quesion that could be raised regards the number of volunteers who would coninue in the research if they had other form of healthcare.
Another important data of our research is that 62.3% of subjects did not know of other treatment opion, i.e., the professional who atended them,
made the referral to the research and was not clear as to possibility of coninuing the treatment and monitoring of this subject. In a study conducted in a private research clinic in Rio de Janeiro, Lacaiva 39
cites that 59% of respondents reported paricipaing in a study to beter understand their health prob -lems and other diseases that they could develop and that only 21% of them paricipated because they either did not access to medical care or such access was diicult in their city.
82.9% of our respondents state that they believe that research should bring some sort of per -sonal beneit. Although it is a mandatory IC item,
respondents did not see their paricipaion as essen -ial for future advances in science, nor they accepted the idea that there was a possibility of not having any beneits. Morrison et al. 40, in a study in the Unit -ed States, found that the inform-ed consent had been given based on altruisic hopes that the research would generate knowledge to reduce the incidence of cancer. Economically disadvantaged paricipants from rural communiies were moivated by the fact of supporing the research, without self-interest.
In this study, 78.1% of respondents report hav -ing read the IC form without the help of another person. Other studies have quesioned if this would be the best process aimed at a greater understanding, although we have not found any signiicant associa -ion. Some studies 41-42 point to the paricipaion of other professional as essenial to the understanding of the IC and paricipant’s safety. According to Sher -lock and Brownie 43, the use of educaional materials in order to obtain the IC, as well as mulimedia in -teracive process leads to increased understanding of the paricipants on the implicaions of the proce -dure. Jofe 32 concluded that the presence of a nurse, a thorough reading of the IC and postponing the signing of the IC in the iniial discussion were factors associated with increased knowledge.
Regarding the way to obtain the IC, we iden -iied a higher percentage of correct answers in the volunteer group that claimed to have taken the IC home. Indeed, the possibility of a new detailed read -ing, as well as discussion with other family members or friends, allows greater depth of understanding. Al -though this does not solve the understanding ability, it certainly facilitates the process, which, however, also depends on not using terms or words whose meaning is not easily grasped, among other factors.
Regarding the use of equipment, there is a proposal in India that IC processes are recorded – audio and image – and kept on ile. These resources should be helpful in documentaion standards, in order to prove that the process was carried out correctly and that the subject did not have doubts about the posiive and negaive aspects of their par -icipaion. However, Sontakke and Kinge 44 point out that, due to poverty and illiteracy, paricipants can be easily led to act in accordance with the research -er’s request, before the recording.
Final consideraions
The mean value of accuracy scores found in this study is not acceptable, and educaional
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measures and changes in speciic procedures must be implemented, seeking to increase the under -standing of the paricipants to provide them with greater security at the ime of signing the IC. Among the suggested changes: producion of educaion -al materi-als for paricipants in clear and objecive language; educaional material for researchers, addressing in a pracical way the basic legislaion, good clinical pracices and the importance of the IC process; provision of permanent courses at the insi -tuion in partnership with the CEP. Other resources that could prove to be efecive, can be used in the IC process such as the inclusion of mulimedia equipment, group discussions and paricipaion of other professionals.
There was no associaion between accuracy score and gender, age, educaion and response ime variables. There was also no evidence of associaion
between accuracy scores and ways of obtaining the IC form, except for the act of taking the signed IC form home. It is advisable to incorporate the sign -ing of the IC form in a second contact as a standard procedure.
This study has limitaions, especially in re -gard to the research scenario. All paricipants were selected in the same place, making it diicult to gen -eralize data. However, the collecion was held in a public insituion, largely relecing the reality of the populaion who uses the Sistema Único de Saúde (Brazilian Uniied Health System – SUS) in the city of Niterói, state of Rio de Janeiro. In order to conirm, compare and deepen the informaion gathered in this research, the performance of further studies is crucial to evaluate the understanding of volunteers from diferent regions of Brazil, even considering dif -ferent social parameters.
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Paricipaion of the Authors
Clarissa de Assumpção designed and performed the data collecion, the analysis and wrote the aricle. Nínive da Silva Pinto took part in the data collecion. Luis Guillermo Coca Velarde took part in the staisical analysis. Osvaldo José Moreira do Nascimento was the co-advisor. Beni Olej designed and advised the study.
Recebido: 31.8.2015 Revisado: 15.2.2016 Aprovado: 24.2.2016
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Annex
Free and informed consent assessment survey - QuACo
Volunteer’s number:
Gender: Age: Educaional level:
Date of signing of the IC form in the study: Healthcare insurance:
Staring ime: Ending ime:
Choose only one answer, that which seems more suitable, thinking about the research you paricipated in or is currently paricipaing. Your opinion is what maters to us.
1. When I signed the IC form, I understood that I was going to paricipate in a study. YES NO I DO NOT KNOW 2. The IC form which I signed was approved by the hospital ethics group before I
received it. YES NO I DO NOT KNOW
3. The main reason for the research is the improvement of future treatment. YES NO I DO NOT KNOW
4. I have no duty or task to follow through. YES NO I DO NOT KNOW
5. I was informed of the length of my paricipaion in the research. YES NO I DO NOT KNOW 6. All research treatments and procedures are already used. YES NO I DO NOT KNOW 7. The research may not bring direct beneits to me. YES NO I DO NOT KNOW 8. By paricipaing in the research, I am helping future paients. YES NO I DO NOT KNOW 9. Due to my paricipaion in the research, the government, sponsors and other indi
-viduals engaged in the study may have access to my medical informaion. YES NO I DO NOT KNOW 10. Everyone will know that I am taking part in a study and will also know about my
disease. YES NO I DO NOT KNOW
11. My physician did not ofer any other opion to me in addiion to the research
treatment. YES NO I DO NOT KNOW
12. The IC form which I signed describes the party who will pay for the costs, if I am
injured or develop any disease as a consequence of the research. YES NO I DO NOT KNOW 13. The IC form which I sign lists the persons with whom I have to contact if I have
any doubts regarding the research or if I feel anything. YES NO I DO NOT KNOW 14. I have to coninue paricipaing in the study even if I do not want. YES NO I DO NOT KNOW 15. I do not know how many volunteers paricipate in the same research I am
paricipaing. YES NO I DO NOT KNOW
16. The physician informed me that the research may end at any moment. YES NO I DO NOT KNOW 17. If there is any change in the research that involves my treatment, I will not know it. YES NO I DO NOT KNOW
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Free and informed consent obtainment form
Choose only one answer, that which seems more suitable, thinking about the day you signed the document to paricipate in the research you were or is currently part of. Your opinion is what maters to us.
1. I took the IC form home.
( ) YES ( ) NO ( ) I DO NOT KNOW
2. I read the IC form alone.
( ) YES ( ) NO ( ) I DO NOT KNOW
3. A relaive or friend helped me understand the IC form. ( ) YES ( ) NO ( ) I DO NOT KNOW
4. The physician (or other professional) explained the IC form to me. ( ) YES ( ) NO ( ) I DO NOT KNOW
5. The physician (or professional) discussed the IC form with me and other group paients. ( ) YES ( ) NO ( ) I DO NOT KNOW
